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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05908864
Other study ID # #FWA00015574
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 30, 2018
Est. completion date December 15, 2020

Study information

Verified date June 2023
Source Beni-Suef University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A prospective study in Beni-Seuf University Hospital that was conducted on 123 adult patients with acute asthma exacerbations. Patients were classified into group (I): received IV magnesium sulfate, group (II): received nebulized magnesium sulfate, and group (III): control group. Blood pressure, respiratory rate, pulse, peak expiratory flow rate (PEFR) measurement using a peak flowmeter, Fischl index and need for hospitalization in patients with acute bronchial asthma were done for all patients before treatment, immediately after the treatment, "30", and "60" min after treatment.


Description:

Inclusion criteria : - adult patients between the ages of 18 and 50 years with acute attack of bronchial asthma - from both sexes - Normal renal function - Normal cardiovascular function Exclusion criteria: - Patients were younger than 18 years or older than 50 years. - Patients suffered from chronic obstructive pulmonary disease, renal disorder and heart failure All patients were subjected to: complete history taking, blood sampling for serum magnesium measurement (on admission before the initial treatment and after the initial treatment) the patients were randomly separated into 3 equal groups each group consists of 41 patients. The 1ST group has been managed by an initial treatment plan (consists of supplemental oxygen therapy to keep oxygen saturation higher than 90%., nebulization of 1 ml salbutamol respirator solution mixed with 9 ml normal saline solution for one session [Farcolin respirator solution: each 20 ml of Farcolin contains Salbutamol sulfate 0.121 gm. Made in Egypt, by: Pharco Pharmaceuticals -Alexandria], Intravenous administration of hydrocortisone 100 mg for a single dose [Solu-Cortef: vial contains powder of 100 mg Sodium hydrocortisone sodium succinate dissolved with 2 ml solvent of sterile bacteriostatic water for IV injection. Manufactured by: Egyptian Int. Pharmaceutical Industries co. (e.i.p.i.co.) - Egypt. Under license of: Pfizer]) plus a single dose (2000 mg) of magnesium sulfate prepared by mixing 20 ml of 10 % magnesium sulfate (2000 MG) [14] ,manufactured by Memphis Pharmaceuticals and Chemical Industries, with 30 ml of distillated water for injection to produce 50 ml of isotonic magnesium sulfate solution (324 MSOM/L) administered intravenously over 1 hour. The 2nd group has been managed by the same initial treatment plan plus a single dose (2000 mg) of magnesium sulfate prepared by mixing 20 ml of 10 % magnesium sulfate (2000 MG) [14] ,manufactured by Memphis Pharmaceuticals and Chemical Industries, with 30 ml of distillated water to produce 50 ml of isotonic magnesium sulfate solution (324 MSOM/L). nebulized using jet nebulizer over 1 hour. The 3rd group has been managed by the same treatment plan Without using magnesium sulfate. (a control group) the following were recorded for each patient at a fixed interval (before the initial treatment, immediately after the initial treatment, 30, and 60 min after the initial treatment): 1. blood pressure, respiratory rate and pulse rate 2. Peak expiratory flow measurement using peak flow meter. 3. Fischl index for relapse and need for hospitalization in patients with acute bronchial asthma. [16[ .


Recruitment information / eligibility

Status Completed
Enrollment 123
Est. completion date December 15, 2020
Est. primary completion date November 22, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - adult patients between the ages of 18 and 50 years with acute attack of bronchial asthma - From both sexes - Normal Renal function - Normal Cardiovascular function Exclusion Criteria: - Patients were younger than 18 years or older than 50 years. - Patients suffered from chronic obstructive pulmonary disease - Patidnts suffered from renal disorder - Patients with heart failure.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Magnesium sulfate
Blood pressure, respiratory rate, pulse, peak expiratory flow rate (PEFR) measurement using a peak flowmeter, Fischl index and need for hospitalization in patients with acute bronchial asthma were done

Locations

Country Name City State
Egypt Faculty of Medicine Beni-suef university Bani Suwayf

Sponsors (1)

Lead Sponsor Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improving pulmonary function tests as PEFR for asthmatic patients Prevention of the progression asthma exacerbation for included subjects 13 monthes
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